drugset / Trial / NCT05334485

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

NCT05334485

Phase 2/3 Recruiting 50 enrolled Stefan Holubar MD MS FACS, FASCRS
RandomizedParallel-groupDouble-blindTreatment

Summary

A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for enrollment. Patients will be randomized to receive either pyridostigmine or placebo in addition to the current elements of standard of care. Patients will also complete the pyridostigmine bromide side effects scale (PBSES) upon enrollment and following each administration of either intervention or placebo to monitor treatment safety and evaluate for the development of side effects.

Timeline

Start
2024-09-03
Primary completion
2026-09
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyridostigmine Small molecule 60 mg Oral

Indications